BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3084095 · Received April 18, 2013

    Report

    Report Number
    2135225-2013-00048
    Event Type
    Other
    Date Received
    April 18, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT HAS NOT RESPONDED TO REQUESTS FOR MERZ AESTHETICS TO SPEAK TO HER INJECTOR. FURTHER INFO HAS NOT BEEN ABLE TO BE OBTAINED. THE DEVICE HISTORY RECORDS FOR RADIESSE THE REPORTED LOT NUMBER WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT SENT AN EMAIL TO MERZ AESTHETICS TO REPORT THAT SHE HAD RADIESSE INJECTED INTO AREAS ON HER FACE 12 DAYS AGO. THERE DOES NOT SEEM TO BE ANY INFECTION HOWEVER, I CONTINUE TO HAVE MODERATE AMOUNT OF SWELLING AND SOME MINIMAL TENDERNESS. THE PT ASKED, "WHAT CAN I DO?" THE PT WAS CONTACTED TO ASK FOR FURTHER INFO REGARDING THE LOT NUMBER, NAME OF FACILITY WHERE INJECTED, NAME OF INJECTOR AND CONTACT INFO, WHERE IN THE FACE INJECTED, HOW MUCH WAS INJECTED, THE DATE OF A F/U VISIT AND FOR PERMISSION TO SPEAK TO HER INJECTOR. ON (B)(6) 2013 THE PT RESPONDED: "I DON'T HAVE THE ANSWER TO YOUR QUESTIONS EXCEPT TO SAY THAT I DID REVISIT THE PRACTITIONER AND MY SWELLING WAS DIAGNOSED AS CELLULITIS. I WAS PRESCRIBED AN ANTIBIOTIC AND THE SWELLING SUBSIDED. I HAVE BEEN FAIRLY HAPPY WITH THE RESULTS OF THE RADIESSE TREATMENT. I WILL NOT RETURN TO THAT PRACTITIONER IN THE FUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167474 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other